Clinical Development and Innovation - KN035 (Envafolimab) has been commercialized since November 2021 and received registration in Macau for treating unresectable or metastatic MSI-H/dMMR adult solid tumor patients in 2024[6]. - KN026 is undergoing three Phase III clinical trials in China, with breakthrough therapy designation granted for HER2-positive gastric cancer patients who failed first-line treatment[7]. - JSKN003, a dual-target HER2 ADC, is in three Phase III clinical trials and has received breakthrough therapy designation for platinum-resistant ovarian cancer, with potential milestone payments up to RMB 3.08 billion[7]. - JSKN033, the world's first subcutaneous ADC combination therapy, has received ethics approval in Australia and is in I/II clinical trials for HER2-expressing advanced solid tumors[8]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, has multiple ongoing clinical trials in China, the US, and Australia, with recent publications in major journals[8]. - Three clinical studies for the HER2 bispecific antibody KN026 are progressing positively, focusing on second-line GC/GEJ and first-line HER2-positive breast cancer[14]. - The ongoing clinical studies for JSKN016 are exploring multiple indications and treatment regimens, demonstrating the company's commitment to innovation[16]. - The JSKN033, a high-concentration combination formulation of ADC and immune checkpoint inhibitors, is the first subcutaneously administered ADC drug to enter clinical trials[16]. - Encouraging PFS and OS benefits were reported in a Phase II clinical trial of KN046 combined with albumin-bound paclitaxel for advanced triple-negative breast cancer, with results published in Nature Communications in February 2024[34]. - JSKN003 demonstrated promising initial anti-tumor activity and good tolerability in a Phase I clinical trial for advanced/metastatic solid tumors, presented at the AACR annual meeting in April 2024[35]. - JSKN003 was granted CDE approval to initiate a Phase III clinical trial for treating platinum-resistant recurrent epithelial ovarian cancer in December 2024[36]. - JSKN033's I/II clinical trial for advanced metastatic malignancies received CDE approval for IND application in December 2024[36]. - KN046 combined with lenvatinib showed promising results in a Phase II clinical study for advanced unresectable or metastatic HCC, published in Nature Communications in February 2025[37]. Financial Performance - The company achieved a significant year-on-year revenue growth of 192.58%, marking its first annual financial profit[18]. - The company reported a revenue of RMB 640,083,000 for the year ending December 31, 2024, representing a significant increase from RMB 218,774,000 in 2023, which is a growth of approximately 192%[32]. - Gross profit for the same period was RMB 579,767,000, up from RMB 163,537,000 in 2023, indicating a gross margin improvement[32]. - The company reported a total comprehensive income for the year ended December 31, 2024, was RMB 166.3 million, compared to a total comprehensive loss of RMB 211.4 million for the previous year[43]. - The company recorded a profit of RMB 166.3 million for the year ended December 31, 2024, compared to a loss of RMB 210.6 million in 2023[56]. - The company achieved a profit before tax of RMB 166,342,000, a turnaround from a loss of RMB 210,593,000 in the previous year[32]. - The gross margin improved to 65%, up from 60% in the previous year, due to cost optimization measures[22]. - The company plans to invest $50 million in research and development over the next two years to accelerate innovation[26]. - The company provided an optimistic outlook, projecting a revenue growth of 30% for the next fiscal year, driven by new product launches and market expansion[25]. Market Expansion and Strategic Initiatives - The global first subcutaneous PD-(L)1 inhibitor, KN035, is expanding its market presence with registration in Macau and development in the Asia-Pacific and Middle East regions[14]. - The company is actively integrating global resources to enhance its international presence and accelerate value transformation through collaborations with leading pharmaceutical companies[18]. - The company is expanding its market presence in Europe, with plans to establish a new distribution center in Germany by mid-2024[27]. - A strategic acquisition of a biotech firm was announced, which is expected to enhance the company's R&D capabilities and product pipeline[24]. - The company has maintained a focus on strategic partnerships and potential acquisitions to enhance its competitive position in the industry[32]. Corporate Governance and Leadership - The company has a strong leadership team with key figures like Ms. Liu, who has extensive experience in human resources and supply chain management, and has been with the group since October 2018[84]. - The board includes independent directors with significant industry experience, such as Dr. Guo, who has been a professor at Nanjing University since May 1999[88]. - The company is committed to maintaining high standards of governance with independent directors overseeing board activities[88]. - The board believes that having the same person serve as both chairman and CEO is beneficial for the company's operations and management[102]. - The company has adopted the principles and code provisions of the corporate governance code as its governance standard[100]. - The company has appointed new independent non-executive directors to enhance board oversight and independent judgment[95]. - The board consists of two executive directors, one non-executive director, and three independent non-executive directors[105]. - The company has established a policy for insider information to comply with the Securities and Futures Ordinance and Listing Rules[104]. - The company has adopted the standard code of conduct as per the Listing Rules Appendix C3, with no reported violations during the reporting period[104]. Employee and Corporate Culture - The company aims to make tumors controllable and treatable diseases, focusing on employee-centric culture and continuous innovation[97]. - The company has strengthened its cultural framework and requires all new employees to participate in onboarding training to understand corporate culture and policies[97]. - The company has a zero-tolerance policy for discrimination based on gender, age, race, nationality, and disability, and aims for improved diversity by 2025[135]. - As of December 31, 2024, the total number of employees is 420, with 45% male (189) and 55% female (231)[134]. - The age distribution of employees shows that 26% (109) are aged 18-30, 72% (301) are aged 31-50, and 2% (10) are over 50[134]. Risk Management and Compliance - The board of directors is responsible for risk management and internal control systems, which are reviewed annually for effectiveness[143]. - The company emphasizes a culture of risk awareness among employees, integrating risk management into strategic and operational processes[144]. - The company has established a whistleblowing policy to address employee concerns confidentially and anonymously[144]. - The board has implemented an anti-corruption policy as part of the corporate governance framework, emphasizing the commitment to ethical business practices[147]. - The company has no significant contingent liabilities or pending litigation that could adversely affect its business or financial condition as of December 31, 2024[77]. Research and Development - The company is continuously improving its biopharmaceutical research and development technology platforms, enhancing its core competitiveness[18]. - The company has established a differentiated and internationally competitive product matrix covering ADC, bispecific antibodies, and other advanced fields[14]. - The company has maintained stable business relationships with major suppliers for approximately six years[170]. - The company has a commitment to high corporate governance standards to protect shareholder interests and enhance company value[99].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） (1)根據首次公開發售後購股權計劃授出購股權；及 (2)根據限制性股份獎勵計劃授出獎勵股份 本公告乃根據《香港聯合交易所有限公司（「聯交所」）證券上市規則》（「上市規 則」）第17.06A、17.06B及17.06C條而作出。 茲提述康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）日期為 2020年4月14日及2021年3月23日的公告、2024年5月21日的通函及2024年6月12 日舉行之股東週年大會投票表決結果公告（「該等公告及通函」），內容有關（其中 包括）採納首次公開發售後購股權計劃（「首次公開發售後購股權計劃」）及採納限 制性股份獎勵計劃（「限制性股份獎勵計劃」）、修訂其各自的計劃規則及更新計劃 授權限額。除另有界定者外，本公告所用詞彙與該等公告及通函所界定者具有相 ...

Financial Performance - The total revenue for the year ended December 31, 2024, was RMB 640,083,000, representing a significant increase of 192.5% compared to RMB 218,774,000 in 2023[4] - Gross profit for the same period was RMB 579,767,000, up from RMB 163,537,000, indicating a gross margin improvement[4] - The company reported a profit before tax of RMB 166,342,000, a turnaround from a loss of RMB 210,593,000 in the previous year[4] - The company’s total comprehensive income for the year ended December 31, 2024, was RMB 166.3 million, compared to a total expenditure of RMB 211.4 million for the year ended December 31, 2023[15] - The company reported a profit of RMB 166.3 million for the year ended December 31, 2024, compared to a loss of RMB 210.6 million for the year ended December 31, 2023[28] - Basic and diluted earnings per share improved to RMB 0.17 in 2024 from a loss per share of RMB 0.22 in 2023[77] Research and Development - Research and development expenses were RMB 404,152,000, slightly decreased from RMB 407,524,000 in 2023, reflecting ongoing investment in innovation[4] - A research collaboration agreement was established with ArriVent BioPharma, Inc. in June 2024 to develop new antibody-drug conjugate products[7] - Completed the final OS analysis of the Phase III clinical trial for KN046 treating advanced squamous NSCLC in September 2024[8] - JSKN003's clinical trial for platinum-resistant ovarian cancer and HER2+ advanced solid tumors presented at ESMO in September 2024[8] - Approved Phase III clinical trial for KN026 combined with docetaxel for HER2+ early or locally advanced breast cancer in October 2024[8] - JSKN033's I/II phase clinical trial results for HER2-expressing advanced or metastatic solid tumors presented at the 2024 Cancer Immunotherapy Conference in November 2024[8] - JSKN003 received CDE approval for Phase III clinical trial in December 2024 for platinum-resistant recurrent epithelial ovarian cancer[8] - JSKN033's IND application for advanced metastatic malignancies approved by CDE in December 2024[8] - JSKN003 received breakthrough therapy designation from CDE in March 2025 for treating platinum-resistant recurrent epithelial ovarian cancer[10] - Multiple IND applications for JSKN016 in NSCLC and non-HER2+ breast cancer approved by CDE in March 2025[10] - KN046 combined with lenvatinib's Phase II clinical trial results published in Nature Communications in February 2025[10] Licensing and Collaborations - The company entered into a licensing agreement with Glenmark for the exclusive rights to develop and commercialize KN035 in several regions, including India and Latin America[6] - Jiangsu Kangning Jierei signed a licensing agreement worth RMB 3.08 billion for JSKN003 in mainland China in September 2024[8] - License fee income for the year ended December 31, 2024, surged to RMB 464.2 million from RMB 7.2 million in 2023, marking an increase of over 6,000%[18] Assets and Liabilities - As of December 31, 2024, total assets amounted to RMB 2,241,755,000, with net assets increasing to RMB 1,831,884,000 from RMB 1,672,112,000 in 2023[5] - Total liabilities related to lease obligations increased to RMB 9,565,000 in 2024 from RMB 4,580,000 in 2023, representing a rise of 109%[82] - The total amount of trade payables rose to RMB 39,222,000 in 2024 from RMB 27,163,000 in 2023, an increase of 44.6%[88] - The company reported contract liabilities of RMB 40,054,000 in 2024, up from RMB 25,460,000 in 2023, indicating a growth of 57.5%[90] Cash Flow and Financing - Cash and cash equivalents increased from RMB 1,086.0 million as of December 31, 2023, to RMB 1,112.1 million as of December 31, 2024[36] - Financing costs decreased from RMB 12.2 million for the year ended December 31, 2023, to RMB 9.9 million for the year ended December 31, 2024, due to changes in working capital borrowings and lower borrowing rates[25] - The company had bank borrowings of RMB 182.2 million as of December 31, 2024, with an interest rate ranging from 2.54% to 2.67%[43] Corporate Governance and Compliance - The company has complied with all applicable corporate governance code provisions for the year ending December 31, 2024, except for the separation of the roles of Chairman and CEO as per provision C.2.1[96] - The company has established an audit committee consisting of three independent non-executive directors, ensuring compliance with the listing rules[100] - The audit committee has reviewed the annual performance for the year ending December 31, 2024, and the financial statements have been audited by Deloitte[100] Future Outlook and Plans - The company plans to continue optimizing manufacturing processes and technology to enhance product quality and reduce costs[14] - The company is actively seeking strategic collaboration opportunities to maximize the commercial value of its global patent assets[14] - The company expects to utilize the remaining net proceeds by the end of 2025, depending on regulatory approvals and market conditions[106] - The company plans to hold its annual general meeting on June 12, 2025[109]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003獲得國家藥監局突破性療法認定 1 關於JSKN003 JSKN003是一種靶向HER2雙表位ADC，其通過糖基定點偶聯技術將拓撲異構酶 I抑制劑連接至抗體KN026（重組人源化抗HER2雙特異性抗體）的N糖基化位點 處。點擊反應偶聯物較馬來醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定 性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應，使 其在HER2表達腫瘤中具有較強的抗腫瘤活性。 關於本公司 本公司是一家中國領先的生物製藥公司，在雙特異性抗體、多功能蛋白質工程及 ADC方面擁有完善的專有技術平台。本公司高度差異化的內部管線由處於不同研 發階段的腫瘤單克隆抗體、雙特異性抗體及ADC組成，包括一種已獲國家藥監局 批准上市及三種處於臨床後期階段的藥 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 董事會會議日期 康寧傑瑞生物製藥（「本公司」）董事（「董事」）會（「董事會」）謹此宣佈，本公司將 於2025年3月25日（星期二）舉行董事會會議，藉以（其中包括）考慮及通過本公司 及其附屬公司截至2024年12月31日止年度之年度業績及其發佈，以及處理其他事 項。 董事長兼執行董事 香港，2025年3月6日 於本公告日期，董事會包括董事長兼執行董事徐霆博士及執行董事劉陽女士；非 執行董事左敏先生；及獨立非執行董事郭子建博士、蔚成先生及吳冬先生。 承董事會命 康寧傑瑞生物製藥 徐霆博士 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 正面盈利預告 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）根據 《香港聯合交易所有限公司證券上市規則》（「《上市規則》」）第13.09(2)(a)條及香港 法例第571章《證券及期貨條例》第XIVA部項下的內幕消息條文（定義見《上市規 則》）作出。 本公司董事（「董事」）會（「董事會」）欣然知會本公司股東（「股東」）及潛在投資 者，基於對本集團截至2024年12月31日止年度（「報告期」）的未經審核綜合管理 賬目的初步評估以及對目前所得最新資料的評估，預期本集團將於截至2024年12 月31日止年度錄得利潤不少於人民幣150.0百萬元，而截至2023年12月31日止年 度則錄得虧損約人民幣210.6百萬元。此乃本公司首次實現年度盈利。 本公司於報告期內轉虧為盈，主要基 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company, indicating a positive outlook on its future growth potential [8]. Core Insights - The company is recognized as a leading developer of innovative oncology therapies, particularly focusing on bispecific antibodies and antibody-drug conjugates (ADCs) [6][19]. - The report highlights the promising clinical data for its products, particularly KN026 and JSKN003, which are expected to significantly contribute to revenue growth in the coming years [8][19]. Summary by Sections Company Overview - The company is a prominent player in the biopharmaceutical industry, specializing in the development of targeted cancer therapies. It has a stable ownership structure and an experienced management team [6][42]. - The company has successfully transitioned to developing bispecific ADCs, leveraging its proprietary glycoengineering technology [6][19]. Product Pipeline - KN026 is the company's second commercial product, a HER2 bispecific antibody that shows superior efficacy compared to traditional therapies. It is currently undergoing multiple clinical trials in China and the US, targeting HER2-positive breast cancer and gastric cancer [2][4][19]. - JSKN003, the company's first ADC product, demonstrates comparable efficacy to DS-8201 but with significantly better safety profiles. It is in advanced clinical trials for HER2 low-expressing breast cancer [7][36][40]. Financial Projections - The company forecasts revenue growth from CNY 305 million in 2024 to CNY 471 million in 2026, with a compound annual growth rate (CAGR) of 39.41% and 35.74% respectively [8]. - The net profit is projected to improve from a loss of CNY 1.46 billion in 2024 to a profit of CNY 630 million by 2026, indicating a turnaround in financial performance [8]. Market Potential - The report estimates that KN026 could reach peak sales of approximately CNY 3.371 billion by 2032, driven by its applications in breast and gastric cancers [19][34]. - The company is positioned to capture significant market share in the HER2-targeted therapy space, with ongoing collaborations enhancing its development capabilities [54].

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 康寧傑瑞生物製藥 呈交日期： 2024年11月29日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | | 庫存股份變動 | | | | | 事件 | 已發行股份（ ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 於2024年SITC年會呈列的JSKN033的I/II期臨床試驗的 最新研究成果 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團自主研發的用於治療HER2 表達晚期或轉移性實體瘤的JSKN033的I/II期臨床試驗（「JSKN033-101」）的最新 研究成果入選2024年SITC年會最新突破性摘要，且於年會期間以壁報形式首次公 佈，本公司的網站http://www.alphamabonc.com亦相應公佈了此研究成果。有關 研究結果概述如下。 JSKN033，HER2雙特異性抗體ADC與PD-L1抑制劑的創新型皮下注射高濃 度 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 康寧傑瑞生物製藥 呈交日期： 2024年10月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | | ...